Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-01631 | Registry Identifier | NCI CTRP |
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The goal of this clinical research study is to learn if 2 cycles of high-dose chemotherapy can help to control germ-cell tumors. The first cycle of chemotherapy will include the drugs gemcitabine, docetaxel, melphalan, and carboplatin. The second cycle of chemotherapy will include the drugs ifosfamide, carboplatin, and etoposide. The safety of these drug combinations will also be studied.
This is an investigational study. Gemcitabine, docetaxel, melphalan, ifosfamide, carboplatin, and etoposide are all FDA-approved and commercially available for the treatment of germ-cell tumors.
Up to 67 patients will be enrolled in this study.
The Study Drugs:
Carboplatin, melphalan, and ifosfamide are designed to damage the DNA (the genetic material) of cancer cells, which may cause the cancer cells to die.
Docetaxel and etoposide are designed to stop the growth of cancer cells, which may cause the cancer cells to die.
Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die. It may also help docetaxel, carboplatin, and melphalan to be more effective by stopping tumor cells from repairing damage caused by these drugs.
Study Drug Administration:
You will receive 2 cycles of high-dose chemotherapy with stem-cell support, 1-2 months apart.
You will receive 1 dose of Outpatient IV at Bevacizumab 7.5mg/kg.
Starting on the first day of your hospital stay, you will begin gargling and swishing Caphosol and Glutamine in your mouth 4 times a day. This is done to help prevent mouth and throat sores.
On Day 2 of your stay in the hospital, through the CVC, you will receive gemcitabine over 4 hours and docetaxel over 2 hours.
On Days 3-5, through the CVC, you will receive gemcitabine over 4 hours, melphalan over 15 minutes, and carboplatin over 2 hours.
On Day 6, you will not receive any study drugs.
On Day 7, you will receive the stem cells through the CVC over about 30-60 minutes.
As part of standard care, you will receive G-CSF (filgrastim) as an injection under your skin daily, starting 5 days after the transplant, until your blood cell levels return to normal.
As part of standard mouth care you will be asked to do mouthwashes 4 times a day with caphosol (artificial saliva) and glutamine.
Two (2) to 4 weeks after you leave the hospital after Cycle 1, you will receive your second cycle of high-dose chemotherapy.
On Days 2-4 of your stay in the hospital, through the CVC, you will receive ifosfamide over 6 hours, etoposide over 2 hours, and carboplatin over 2 hours.
On Days 5-6, you will not receive any study drugs.
On Day 7, you will receive the stem cells through the CVC over about 30-60 minutes.
Study Visits:
About 1 month, 100 days, 6 months and 1 year after your second stem cell transplant, the following tests and procedures will be performed:
Length of Study:
You will be off study after about 1 year from your second transplant. You will be taken off study early if the disease gets worse or if you experience any intolerable side effects.
Long-Term Follow-up:
If your doctor thinks it is needed, you may have follow-up visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cycle # 1 | Experimental | First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC |
|
| Cycle #2 | Experimental | Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | 1800 mg/m^2 IV over 3 hours on Days -5 to Day -2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With 2-year Event-Free Survival (EFS) | Event-free survival estimated from the first day of High-Dose Course Cycle #1 (Day -6) until tumor progression, relapse, or death from any cause. | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Number of Participants alive and disease free 1 year post treatment completion. | 1 year post treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Yago Nieto, MD, PHD | M.D. Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77007 | United States | ||
| Fred Hutchinson Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26199392 | Derived | Nieto Y, Tu SM, Bassett R, Jones RB, Gulbis AM, Tannir N, Kingham A, Ledesma C, Margolin K, Holmberg L, Champlin R, Pagliaro L. Bevacizumab/high-dose chemotherapy with autologous stem-cell transplant for poor-risk relapsed or refractory germ-cell tumors. Ann Oncol. 2015 Oct;26(10):2125-32. doi: 10.1093/annonc/mdv310. Epub 2015 Jul 21. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
Not provided
Not provided
All participants were registered in MD Anderson Cancer Center.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT | First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) You will receive 1 dose of Outpatient IV at Bevacizumab 7.5mg/kg. HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC Gemcitabine: 1800 mg/m^2 IV over 3 hours on Days -5 to Day -2. Docetaxel: Docetaxel 300 mg/m^2 IV over 2 hours on Day -5. Melphalan: 50 mg/m^2 IV over 15 minutes on Days -4 to Day -2. Carboplatin: Cycle 1: 333 mg/m^2 IV over 2 hours on Days -4 to -2. Stem Cell Transplant: Stem cell infusion on Day 0. Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #2: Ifosfamide/Carboplatin/Etoposide (ICE) + PBPC Carboplatin: Cycle 1: 333 mg/m^2 IV over 2 hours on Days -4 to -2. Cycle #2: 300 mg/m^2 IV over 2 hours on Days -6 to -3. Mesna: 3,000 mg/m^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4. Ifosfamide: 3,000 mg/m^2 IV over 6 hours on Days -6 to -3 Etoposide: 200 mg/m^2 IV over 3 hours, every 12 hours on Days -6 to -4. Stem Cell Transplant: Stem cell infusion on Day 0. |
| FG001 | Cohort 2: HD GeM-DMC+ ICE for Refractory GCT | First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC Gemcitabine: 1800 mg/m^2 IV over 3 hours on Days -5 to Day -2. Docetaxel: Docetaxel 300 mg/m^2 IV over 2 hours on Day -5. Melphalan: 50 mg/m^2 IV over 15 minutes on Days -4 to Day -2. Carboplatin: Cycle 1: 333 mg/m^2 IV over 2 hours on Days -4 to -2. Stem Cell Transplant: Stem cell infusion on Day 0. Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC Carboplatin: Cycle 1: 333 mg/m^2 IV over 2 hours on Days -4 to -2. Cycle #2: 300 mg/m^2 IV over 2 hours on Days -6 to -3. Mesna: 3,000 mg/m^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4. Ifosfamide: 3,000 mg/m^2 IV over 6 hours on Days -6 to -3 Etoposide: 200 mg/m^2 IV over 3 hours, every 12 hours on Days -6 to -4. Stem Cell Transplant: Stem cell infusion on Day 0. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT | First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) You will receive 1 dose of Outpatient IV at Bevacizumab 7.5mg/kg. HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC Gemcitabine: 1800 mg/m^2 IV over 3 hours on Days -5 to Day -2. Docetaxel: Docetaxel 300 mg/m^2 IV over 2 hours on Day -5. Melphalan: 50 mg/m^2 IV over 15 minutes on Days -4 to Day -2. Carboplatin: Cycle 1: 333 mg/m^2 IV over 2 hours on Days -4 to -2. Stem Cell Transplant: Stem cell infusion on Day 0. Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC Carboplatin: Cycle 1: 333 mg/m^2 IV over 2 hours on Days -4 to -2. Cycle #2: 300 mg/m^2 IV over 2 hours on Days -6 to -3. Mesna: 3,000 mg/m^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4. Ifosfamide: 3,000 mg/m^2 IV over 6 hours on Days -6 to -3 Etoposide: 200 mg/m^2 IV over 3 hours, every 12 hours on Days -6 to -4. Stem Cell Transplant: Stem cell infusion on Day 0. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With 2-year Event-Free Survival (EFS) | Event-free survival estimated from the first day of High-Dose Course Cycle #1 (Day -6) until tumor progression, relapse, or death from any cause. | Posted | Count of Participants | Participants | 2 Years |
|
2 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT | First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) You will receive 1 dose of Outpatient IV at Bevacizumab 7.5mg/kg. HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC Gemcitabine: 1800 mg/m^2 IV over 3 hours on Days -5 to Day -2. Docetaxel: Docetaxel 300 mg/m^2 IV over 2 hours on Day -5. Melphalan: 50 mg/m^2 IV over 15 minutes on Days -4 to Day -2. Carboplatin: Cycle 1: 333 mg/m^2 IV over 2 hours on Days -4 to -2. Stem Cell Transplant: Stem cell infusion on Day 0. Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC Carboplatin: Cycle 1: 333 mg/m^2 IV over 2 hours on Days -4 to -2. Cycle #2: 300 mg/m^2 IV over 2 hours on Days -6 to -3. Mesna: 3,000 mg/m^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4. Ifosfamide: 3,000 mg/m^2 IV over 6 hours on Days -6 to -3 Etoposide: 200 mg/m^2 IV over 3 hours, every 12 hours on Days -6 to -4. Stem Cell Transplant: Stem cell infusion on Day 0. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALK increased | Investigations | CTCAE (4.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yago Nieto, PhD. / Stem Cell Transplantation Department | University of Texas MD Anderson Cancer Center | 713-792-8750 | ynieto@mdanderson.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 13, 2017 | Feb 28, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D013736 | Testicular Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005834 | Genital Neoplasms, Male |
Not provided
Not provided
| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077143 | Docetaxel |
| D008558 | Melphalan |
| D016190 | Carboplatin |
| D015080 | Mesna |
| D007069 | Ifosfamide |
| D005047 | Etoposide |
| D033581 | Stem Cell Transplantation |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Docetaxel | Drug | Docetaxel 300 mg/m^2 IV over 2 hours on Day -5. |
|
|
| Melphalan | Drug | 50 mg/m^2 IV over 15 minutes on Days -4 to Day -2. |
|
|
| Carboplatin | Drug | Cycle 1: 333 mg/m^2 IV over 2 hours on Days -4 to -2. Cycle #2: 300 mg/m^2 IV over 2 hours on Days -6 to -3. |
|
|
| Mesna | Drug | 3,000 mg/m^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4. |
|
|
| Ifosfamide | Drug | 3,000 mg/m^2 IV over 6 hours on Days -6 to -3 |
|
|
| Etoposide | Drug | 200 mg/m^2 IV over 3 hours, every 12 hours on Days -6 to -4. |
|
|
| Stem Cell Transplant | Procedure | Stem cell infusion on Day 0. |
|
|
| Seattle |
| Washington |
| 98109 |
| United States |
| Unrelated |
|
| BG001 | Cohort 2: HD GeM-DMC+ ICE for Refractory GCT | First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC Gemcitabine: 1800 mg/m^2 IV over 3 hours on Days -5 to Day -2. Docetaxel: Docetaxel 300 mg/m^2 IV over 2 hours on Day -5. Melphalan: 50 mg/m^2 IV over 15 minutes on Days -4 to Day -2. Carboplatin: Cycle 1: 333 mg/m^2 IV over 2 hours on Days -4 to -2. Stem Cell Transplant: Stem cell infusion on Day 0. Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC Carboplatin: Cycle 1: 333 mg/m^2 IV over 2 hours on Days -4 to -2. Cycle #2: 300 mg/m^2 IV over 2 hours on Days -6 to -3. Mesna: 3,000 mg/m^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4. Ifosfamide: 3,000 mg/m^2 IV over 6 hours on Days -6 to -3 Etoposide: 200 mg/m^2 IV over 3 hours, every 12 hours on Days -6 to -4. Stem Cell Transplant: Stem cell infusion on Day 0. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Cohort 2: HD GeM-DMC+ ICE for Refractory GCT | First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC Gemcitabine: 1800 mg/m^2 IV over 3 hours on Days -5 to Day -2. Docetaxel: Docetaxel 300 mg/m^2 IV over 2 hours on Day -5. Melphalan: 50 mg/m^2 IV over 15 minutes on Days -4 to Day -2. Carboplatin: Cycle 1: 333 mg/m^2 IV over 2 hours on Days -4 to -2. Stem Cell Transplant: Stem cell infusion on Day 0. Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC Carboplatin: Cycle 1: 333 mg/m^2 IV over 2 hours on Days -4 to -2. Cycle #2: 300 mg/m^2 IV over 2 hours on Days -6 to -3. Mesna: 3,000 mg/m^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4. Ifosfamide: 3,000 mg/m^2 IV over 6 hours on Days -6 to -3 Etoposide: 200 mg/m^2 IV over 3 hours, every 12 hours on Days -6 to -4. Stem Cell Transplant: Stem cell infusion on Day 0. |
|
|
| Secondary | Overall Survival | Number of Participants alive and disease free 1 year post treatment completion. | Posted | Count of Participants | Participants | 1 year post treatment |
|
|
|
| 22 |
| 41 |
| 7 |
| 41 |
| 41 |
| 41 |
| EG001 | Cohort 2: HD GeM-DMC+ ICE for Refractory GCT | First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC Gemcitabine: 1800 mg/m^2 IV over 3 hours on Days -5 to Day -2. Docetaxel: Docetaxel 300 mg/m^2 IV over 2 hours on Day -5. Melphalan: 50 mg/m^2 IV over 15 minutes on Days -4 to Day -2. Carboplatin: Cycle 1: 333 mg/m^2 IV over 2 hours on Days -4 to -2. Stem Cell Transplant: Stem cell infusion on Day 0. Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC Carboplatin: Cycle 1: 333 mg/m^2 IV over 2 hours on Days -4 to -2. Cycle #2: 300 mg/m^2 IV over 2 hours on Days -6 to -3. Mesna: 3,000 mg/m^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4. Ifosfamide: 3,000 mg/m^2 IV over 6 hours on Days -6 to -3 Etoposide: 200 mg/m^2 IV over 3 hours, every 12 hours on Days -6 to -4. Stem Cell Transplant: Stem cell infusion on Day 0. | 12 | 23 | 2 | 23 | 23 | 23 |
| AST increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Bacterial | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Bleeding (no GI no PUL) | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ejection fraction decreased | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Fungal | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Gastrointestinal bleeding | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Oral Mucositis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Viral | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| DAH | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
|
| ALT increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| AST increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Bacterial | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Bleeding (no GI no PUL) | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| HSCT related microangiopathy (TA-TMA) | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysrhythmia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chest pain | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ejection fraction decreased | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flu like syndrome | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fluid overload | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fungal | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Gastrointestinal bleeding | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Oral mucositis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lower Gl track obstruction | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| GI OTH | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hemorrhagic Cystitis | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| T bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Palmar-plantar erythrodysesthesia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Peripheral neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| renal failure & fluid retention | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| SK DES | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin discoloration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin Disorders | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Viral | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| DAH | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cystitis noninfective | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D014565 |
| Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004700 | Endocrine System Diseases |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D056831 | Coordination Complexes |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D003520 | Cyclophosphamide |
| D010752 | Phosphoramide Mustards |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010078 | Oxazines |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |